- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07770620
Effects of Face-to-Face Versus Telerehabilitation-Based Circuit Training in People With Multiple Sclerosis
This randomized controlled study was planned to compare the effects of delivering the same exercise content face-to-face and through telerehabilitation in individuals diagnosed with multiple sclerosis. All participants will receive circuit training for 8 weeks. The program will consist of two sessions per week, each lasting approximately 60 minutes. Assessments will be performed before and after treatment. Participants will be divided into two groups according to the mode of delivery: face-to-face and telerehabilitation. Telerehabilitation sessions will be conducted synchronously (via live connection) twice a week.
The study population will consist of adults aged 18-65 years with a diagnosis of MS who attend Istanbul University-Cerrahpaşa Hospital. Individuals who meet the eligibility criteria will be included in the study on a voluntary basis after being informed about the study. Participants will be allocated to the groups using stratified randomization based on EDSS scores.
The circuit training program will consist of endurance-, resistance-, and balance-focused exercise components. The effects of the interventions will be evaluated in terms of walking endurance and speed, functional mobility, dynamic balance, lower-extremity functional muscle strength, perceived walking ability, fatigue, quality of life, and the physical and psychological impact of MS. All assessments will be performed before the intervention and at the end of the 8-week program.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Multiple sclerosis (MS) is a chronic disease characterized by inflammation, demyelination, and axonal loss in the central nervous system, affecting functions such as balance, walking, muscle strength, and fatigue, thereby reducing individuals' participation in activities and quality of life. Balance, coordination, strengthening, and aerobic exercise approaches are widely used in MS rehabilitation, and these methods are supported by a high level of evidence for improving functional capacity.
One method that allows these approaches to be combined and structured around functional tasks is circuit training, in which exercises are organized as consecutive stations with short rest intervals. Circuit training is defined as a comprehensive exercise model that targets endurance, balance, strength, and motor control components within the same session. Straudi et al. demonstrated that supervised and home-based task-oriented circuit training improved walking endurance and had positive effects on walking speed, functional mobility, fatigue, and muscle oxygen consumption. Doğan et al. reported that telerehabilitation- and virtual reality-supported circuit training improved trunk control, upper extremity function, and ataxia severity. In a meta-analysis conducted by Du et al., circuit training interventions were reported to have positive effects on balance, walking, fatigue, and quality of life in individuals with MS.
However, studies directly investigating circuit training in individuals with MS are limited. In recent years, telerehabilitation has emerged as a contemporary approach that provides access independent of distance; however, the need for further controlled studies to strengthen the level of evidence in MS has been emphasized.
The aim of this study is to investigate and compare the effects of an 8-week circuit training program delivered face-to-face and through synchronous telerehabilitation on walking capacity, functional mobility, lower-extremity muscle strength, fatigue, activities of daily living, and quality of life in individuals with MS.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Yonca Zenginler Yazgan, PhD
- Telefonnummer: +905326006294
- E-Mail: y.zenginleryazgan@iuc.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Adennur Tayboğa, BSc
- Telefonnummer: +905369651764
- E-Mail: adennurtayboga@gmail.com
Studienorte
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Istanbul
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Istanbul, Istanbul, Türkei (türkiye), 34147
- Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Diagnosis of multiple sclerosis Age between 18 and 65 years Expanded Disability Status Scale (EDSS) score between 2.0 and 5.5 Mini-Mental State Examination (MMSE) score greater than 24 No relapse within the past 3 months Ability to walk at least 100 meters with or without an assistive device Willingness to participate in the study and provision of written informed consent
Exclusion Criteria:
- Botulinum toxin treatment for spasticity or a surgical procedure within the past 6 months Participation in a regular physiotherapy or rehabilitation program within the past 3 months Presence of a secondary neurological, orthopedic, or systemic disease that prevents independent standing and walking Presence of severe peripheral vestibular dysfunction Presence of a medical condition that may prevent participation in exercise Failure to provide written informed consent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Face-to-Face
Participants in this group will receive an 8-week circuit training program delivered face-to-face in a clinical setting.
The program will be conducted twice a week, with each session lasting approximately 60 minutes, and will include endurance, resistance, and balance exercises.
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Participants will receive an 8-week circuit training program delivered face-to-face in a clinical setting.
The program will be conducted twice a week, with each session lasting approximately 60 minutes.
The circuit training program will include endurance, resistance, and balance exercises.
Each exercise station will consist of 3 minutes of exercise followed by 2 minutes of rest.
Participants will complete two circuits, with a 10-minute rest period between circuits.
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Experimental: Telerehabilitation-Based
Participants in this group will receive the same 8-week circuit training program through synchronous telerehabilitation.
The program will be conducted twice a week through live online sessions, with each session lasting approximately 60 minutes, and will include endurance, resistance, and balance exercises.
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Participants will receive the same 8-week circuit training program through synchronous telerehabilitation.
The program will be conducted twice a week through live online sessions, with each session lasting approximately 60 minutes.
The circuit training program will include endurance, resistance, and balance exercises.
Each exercise station will consist of 3 minutes of exercise followed by 2 minutes of rest.
Participants will complete two circuits, with a 10-minute rest period between circuits.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Walking Endurance: 6-Minute Walk Test (6MWT)
Zeitfenster: Baseline and post-intervention at Week 8
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Walking endurance will be assessed using the 6-Minute Walk Test.
During the test, participants will be instructed to walk as far as possible for 6 minutes along a predefined, level course.
At the end of the test, the total distance covered will be recorded in meters, and this value will reflect the individual's functional walking capacity and endurance.
Any assistive device used by the participant, the need for rest, and the development of symptoms during the test will also be recorded.
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Baseline and post-intervention at Week 8
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Walking Speed: Timed 25-Foot Walk Test (T25FW)
Zeitfenster: Baseline and post-intervention at Week 8
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Walking speed will be assessed using the Timed 25-Foot Walk Test.
Participants will be instructed to walk a distance of 25 feet, approximately 7 meters, safely but as quickly as possible.
The time required to complete the test will be recorded in seconds; a shorter completion time indicates better short-distance walking performance.
This test will be used to objectively assess ambulation and lower-extremity function in individuals with MS.
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Baseline and post-intervention at Week 8
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Functional Mobility: Timed Up and Go Test (TUG)
Zeitfenster: Baseline and post-intervention at Week 8
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Functional mobility will be assessed using the Timed Up and Go Test.
The participant will begin in a seated position on a chair; upon command, the participant will stand up, walk a distance of 3 meters, turn around, return to the chair, and sit down.
The time required to complete the test will be recorded in seconds.
This test provides an integrated assessment of functional movements frequently used in daily life, including sit-to-stand, walking, turning, and sitting down.
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Baseline and post-intervention at Week 8
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Dynamic Balance: Mini-Balance Evaluation Systems Test (Mini-BESTest)
Zeitfenster: Baseline and post-intervention at Week 8
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Dynamic balance will be assessed using the Mini-BESTest.
The Mini-BESTest consists of tasks involving anticipatory postural control, reactive postural responses, sensory orientation, and dynamic gait.
The participant's ability to use different balance strategies, generate postural responses, and maintain stability during movement will be assessed.
Each item will be scored according to performance, and the total score will provide information about the level of dynamic balance.
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Baseline and post-intervention at Week 8
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Lower-Extremity Functional Muscle Strength: Five Times Sit-to-Stand Test (5xSTS)
Zeitfenster: Baseline and post-intervention at Week 8
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Lower-extremity functional muscle strength will be assessed using the Five Times Sit-to-Stand Test.
Participants will be instructed to stand up from and sit down on a standard chair five consecutive times, preferably without using their arms.
The time required to complete the test will be recorded in seconds.
A shorter completion time will indicate better lower-extremity functional muscle strength and functional transfer performance.
Participants will be observed for safety during the test, and the use of an assistive device will be recorded if necessary.
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Baseline and post-intervention at Week 8
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Patient-Perceived Impact on Walking Ability: Multiple Sclerosis Walking Scale-12 (MSWS-12)
Zeitfenster: Baseline and post-intervention at Week 8
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The patient-perceived impact on walking ability will be assessed using the MSWS-12.
The scale consists of 12 items that assess the impact of MS on walking function based on patient-reported outcomes.
Participants will rate the difficulties they have experienced while walking and the impact of these difficulties on their daily lives.
Higher scores indicate a greater perceived limitation in walking due to MS.
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Baseline and post-intervention at Week 8
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Fatigue: Modified Fatigue Impact Scale (MFIS)
Zeitfenster: Baseline and post-intervention at Week 8
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Fatigue will be assessed using the Modified Fatigue Impact Scale.
The MFIS is a patient-reported measure that assesses the physical, cognitive, and psychosocial impact of fatigue on daily life.
Participants will indicate the extent to which fatigue has affected their activities, cognitive functioning, social life, and overall functioning.
Higher total scores indicate a greater impact of fatigue on daily life.
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Baseline and post-intervention at Week 8
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Quality of Life: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)
Zeitfenster: Baseline and post-intervention at Week 8
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Quality of life will be assessed using the MusiQoL.
The MusiQoL is a patient-reported measure developed to assess MS-specific health-related quality of life.
The questionnaire evaluates different dimensions of quality of life, including activities of daily living, psychological well-being, symptoms, relationships with friends, family relationships, coping, relationship with the health care system, and the overall impact of the disease on the individual.
Higher scores indicate better perceived quality of life.
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Baseline and post-intervention at Week 8
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Physical and Psychological Impact of Multiple Sclerosis: Multiple Sclerosis Impact Scale-29 (MSIS-29)
Zeitfenster: Baseline and post-intervention at Week 8
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The physical and psychological impact of MS will be assessed using the MSIS-29.
The scale consists of 29 items that assess the patient-reported impact of MS on daily life, physical functioning, mobility, emotional status, and overall well-being.
The physical and psychological subscales can be evaluated separately.
Higher total and subscale scores indicate a greater perceived impact of the disease on the individual.
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Baseline and post-intervention at Week 8
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Motl RW, Cohen JA, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):704-710. doi: 10.1177/1352458517690823. Epub 2017 Feb 16.
- Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.
- Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.
- Chisari C, Venturi M, Bertolucci F, Fanciullacci C, Rossi B. Benefits of an intensive task-oriented circuit training in Multiple Sclerosis patients with mild disability. NeuroRehabilitation. 2014;35(3):509-18. doi: 10.3233/NRE-141144.
- Lehmann I, Thaler I, Luder G, Damm U, Walti C, Steinheimer S, Verra ML, Muri RM, Nyffeler T, Vanbellingen T, Kamm CP. Standardized, comprehensive, hospital-based circuit training in people with multiple sclerosis: results on feasibility, adherence and satisfaction of the training intervention. Eur J Phys Rehabil Med. 2020 Jun;56(3):279-285. doi: 10.23736/S1973-9087.20.06191-2. Epub 2020 Mar 30.
- Ozden F, Ozkeskin M, Yuceyar N. The reliability and validity of the Turkish version of the multiple sclerosis impact scale-29. Turk J Med Sci. 2022 Aug;52(4):1216-1222. doi: 10.55730/1300-0144.5426. Epub 2022 Aug 10.
- Armutlu K, Keser I, Korkmaz N, Akbiyik DI, Sumbuloglu V, Guney Z, Karabudak R. Psychometric study of Turkish version of Fatigue Impact Scale in multiple sclerosis patients. J Neurol Sci. 2007 Apr 15;255(1-2):64-8. doi: 10.1016/j.jns.2007.01.073. Epub 2007 Mar 6.
- Dib H, Tamam Y, Terzi M, Hobart J. Testing patient-reported outcome measurement equivalence in multinational clinical trials: An exemplar using the 12-item Multiple Sclerosis Walking Scale. Mult Scler J Exp Transl Clin. 2017 Sep 1;3(3):2055217317728740. doi: 10.1177/2055217317728740. eCollection 2017 Jul-Sep.
- Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.
- Dogruoz Karatekin B, Icagasioglu A, Pasin O. Validity, reliability and minimal detectable change of Mini-BESTest Turkish version in neurological disorders. Acta Neurol Belg. 2023 Aug;123(4):1519-1525. doi: 10.1007/s13760-023-02299-7. Epub 2023 Jun 16.
- Wetzel JL, Fry DK, Pfalzer LA. Six-minute walk test for persons with mild or moderate disability from multiple sclerosis: performance and explanatory factors. Physiother Can. 2011 Spring;63(2):166-80. doi: 10.3138/ptc.2009-62. Epub 2011 Apr 13.
- Cardini R, Corrini C, Bertoni R, Anastasi D, Cattaneo D, Gervasoni E. Exploring the effectiveness of circuit training rehabilitation on balance, gait, and fatigue in multiple sclerosis: a systematic review and meta-analysis. Physiotherapy. 2024 Dec;125:101413. doi: 10.1016/j.physio.2024.101413. Epub 2024 Jul 20.
- Dogan M, Ayvat E, Kilinc M. Telerehabilitation versus virtual reality supported task-oriented circuit therapy on upper limbs and trunk functions in patients with multiple sclerosis: A randomized controlled study. Mult Scler Relat Disord. 2023 Mar;71:104558. doi: 10.1016/j.msard.2023.104558. Epub 2023 Feb 11.
- Straudi S, De Marco G, Martinuzzi C, Baroni A, Lamberti N, Brondi L, Da Roit M, Pizzongolo LDM, Basaglia N, Manfredini F. Combining a supervised and home-based task-oriented circuit training improves walking endurance in patients with multiple sclerosis. The MS_TOCT randomized-controlled trial. Mult Scler Relat Disord. 2022 Apr;60:103721. doi: 10.1016/j.msard.2022.103721. Epub 2022 Mar 5.
- Haki M, Al-Biati HA, Al-Tameemi ZS, Ali IS, Al-Hussaniy HA. Review of multiple sclerosis: Epidemiology, etiology, pathophysiology, and treatment. Medicine (Baltimore). 2024 Feb 23;103(8):e37297. doi: 10.1097/MD.0000000000037297.
- Vanbellingen T, Kamm CP. Neurorehabilitation Topics in Patients with Multiple Sclerosis: From Outcome Measurements to Rehabilitation Interventions. Semin Neurol. 2016 Apr;36(2):196-202. doi: 10.1055/s-0036-1579694. Epub 2016 Apr 26.
- Bjartmar C, Trapp BD. Axonal and neuronal degeneration in multiple sclerosis: mechanisms and functional consequences. Curr Opin Neurol. 2001 Jun;14(3):271-8. doi: 10.1097/00019052-200106000-00003.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
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Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- iuc-telerehab-circuittraining
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